BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR SYSTEM

    MDR report key: 24815972 · Received April 8, 2026

    Report

    Report Number
    9615350-2026-00003
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    February 6, 2026
    Report Date
    April 8, 2026
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    ITI
    UDI-DI
    00754014710065
    PMA / PMN Number
    K150574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT WHEELCHAIR SYSTEM WAS SHIPPED BY MOTION CONCEPTS LP TO MEDBLOC, THE MOTION CONCEPTS U.S. IMPORTER/DISTRIBUTOR, ON (B)(6) 2020, IN ACCORDANCE WITH A DEALER ORDER. THE SYSTEM WAS SUBSEQUENTLY SOLD BY MEDBLOC TO NUMOTION (AURORA, CO) ON (B)(6) 2020. A REVIEW OF THE DEVICE HISTORY INDICATES THAT THE SYSTEM WAS ORIGINALLY SUPPLIED WITH A 4-WAY PUSH BUTTON SWITCH, WHICH WAS LATER REPLACED WITH A 4-WAY TOUCH SWITCH ON (B)(6) 2025. FOLLOWING NOTIFICATION OF THE REPORTED INCIDENT, THE END-USER'S HUSBAND REQUESTED REPLACEMENT COMPONENTS, INCLUDING A 4-WAY PUSH BUTTON SWITCH AND A SPLITTER. THESE COMPONENTS WERE SUBSEQUENTLY SHIPPED BY MOTION CONCEPTS. THE END-USER'S HUSBAND ALSO REPORTED THAT THE BATHROOM SINK MAY HAVE INADVERTENTLY ACTIVATED THE DEVICE SWITCH. MOTION CONCEPTS CONDUCTED A REVIEW OF AVAILABLE COMPLAINT DATA AND DETERMINED THAT THIS IS THE FIRST REPORTED OCCURRENCE OF A SIMILAR ISSUE. TO FACILITATE FURTHER EVALUATION, MOTION CONCEPTS REQUESTED THE RETURN OF THE SUBJECT DEVICE. HOWEVER, THE PRODUCT HAS NOT BEEN RECEIVED AS OF (B)(6) 2026. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, A DEVICE MALFUNCTION CANNOT BE CONFIRMED. GIVEN THE REPORT THAT THE BATHROOM SINK MAY HAVE INADVERTENTLY TRIGGERED THE DEVICE SWITCH, THE INCIDENT MAY HAVE BEEN THE RESULT OF UNINTENTIONAL USE ERROR. HOWEVER, AS THE INCIDENT INVOLVED A MOTION CONCEPTS WHEELCHAIR AND RESULTED IN USER INJURY, THIS REPORT IS BEING SUBMITTED IN ACCORDANCE WITH MDR REPORTING REQUIREMENTS. IF THE SUBJECT DEVICE IS RETURNED AND SUBSEQUENT EVALUATION IMPACTS THE CURRENT ASSESSMENT, A FOLLOW-UP REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 0

    ON MARCH 11, 2026, MOTION CONCEPTS LP WAS NOTIFIED BY ITS AUTHORIZED DISTRIBUTOR, MEDBLOC, OF AN INCIDENT INVOLVING A MOTION CONCEPTS WHEELCHAIR IN THE FIELD. THE DISTRIBUTOR INDICATED THAT THE WHEELCHAIR SYSTEM HAD BEEN SOLD TO NUMOTION (AURORA, CO), WHICH IS RESPONSIBLE FOR ONGOING SERVICE AND MAINTENANCE OF THE UNIT. ACCORDING TO THE REPORT, THE END-USER WAS OPERATING THE WHEELCHAIR AND WAS MANEUVERING THE DEVICE UNDERNEATH A BATHROOM SINK AT THE TIME OF THE INCIDENT. DURING THIS ACTIVITY, AN UNINTENDED ACTIVATION OF THE POWER LEG REST OCCURRED. IT WAS REPORTED BY THE END-USER'S HUSBAND THAT CONTACT WITH THE BATHROOM SINK MAY HAVE INADVERTENTLY ACTIVATED A DEVICE SWITCH. AS A RESULT OF THE UNINTENDED MOVEMENT, THE END-USER'S LEFT FOOT MADE FORCEFUL CONTACT WITH A WALL, LEADING TO A FRACTURED LEFT ANKLE AND SIGNIFICANT BRUISING TO THE TOES ON THE LEFT FOOT. THE PATIENT SOUGHT EMERGENCY MEDICAL CARE, WHERE A THREE-WAY SPLINT WAS APPLIED. SHE WAS SUBSEQUENTLY TRANSFERRED TO A LOCAL HOSPITAL FOR FURTHER EVALUATION AND TREATMENT AND REMAINED HOSPITALIZED FOR APPROXIMATELY THREE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495967 POWERED WHEELCHAIR SYSTEM WHEELCHAIR ITI MOTION CONCEPTS LP 45T-12L-RESR-MAXX 00754014710065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization